Recall Z-2118-2021— Exactech, Inc.

Name: FDA recall Z-2118-2021
Creator: U.S. Food and Drug Administration
Published: 2021-06-29

Class II · Ongoing

Class II FDA medical device recall by Exactech, Inc., initiated 2021-06-29. It names 3 FDA 510(k) clearances: K121392, K070479, K051556. Product: Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-36-XX, Acumatch GXL 0 Degree Liner, 36mm; and Novation GXL Liner, Neutral, 36mm. Orthopedic hip implant component.. Reason: Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning..

Recalling firm: Exactech, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2021-06-29
Firm location: Gainesville, FL, United States

510(k) clearances named in this recall

3 on FDA's record

K121392 — NOVATION CROWN CUP LINERS; NEUTRAL, LIPPED, +5MM LATERALIZED, +5/10 DEGREEExactech, Inc.·cleared 2013-01-16
K070479 — EXACTECH NOVATION CROWN CUP AND LINERSExactech, Inc.·cleared 2007-03-15
K051556 — ACUMATCH A-SERIES CONNEXION GXL ENHANCED CROSSLINKED POLYTHYLENEExactech, Inc.·cleared 2005-09-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-36-XX, Acumatch GXL 0 Degree Liner, 36mm; and Novation GXL Liner, Neutral, 36mm. Orthopedic hip implant component.

Reason for recall

Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.

Data sourced from openFDA. This site is unofficial and independent of the FDA.